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Director, Software Engineering
3 months ago
Job Overview:
The Director of Software Engineering will be responsible for overseeing all software development activities for our medical devices. This role requires a deep understanding of the medical device industry, including regulatory requirements, software development lifecycle, and quality assurance standards. The ideal candidate will have a strong background in C/C++ programming and a proven track record of leading engineering teams in the successful delivery of complex projects.
Key Responsibilities:
Lead and manage the software engineering team, providing technical guidance, mentorship, and career development.
Oversee the entire software development lifecycle, including planning, design, implementation, testing, deployment, and maintenance.
Collaborate with cross-functional teams, including hardware engineering, quality assurance, regulatory affairs, and clinical affairs, to ensure seamless integration and compliance of software components.
Develop and implement software development processes and best practices to enhance productivity, quality, and efficiency.
Drive innovation by staying current with industry trends, emerging technologies, and best practices in software engineering and medical devices.
Manage project timelines, budgets, and resources to ensure on-time and within-budget delivery of software projects.
Participate in risk management activities, including the identification, assessment, and mitigation of software-related risks.
Prepare and present technical documentation, reports, and presentations to stakeholders, including senior management, regulatory bodies, and customers.
Foster a culture of continuous improvement, collaboration, and excellence within the software engineering team.
Qualifications:
Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field. Advanced degrees or certifications in medical device software development are a plus.
Minimum of 10 years of experience in software engineering, with at least 5 years in a leadership role within the medical device industry.
Strong proficiency in C/C++ programming and a solid understanding of software architecture and design principles.
In-depth knowledge of medical device regulations and standards, including ISO 13485, IEC 62304, and FDA guidelines.
Proven experience in managing the software development lifecycle and leading teams in the delivery of complex software projects.
Excellent problem-solving skills and the ability to make sound technical decisions under pressure.
Strong interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams and present technical information to non-technical stakeholders.
Experience with risk management, quality assurance, and validation/verification processes in the context of medical device software.
Demonstrated ability to drive innovation and stay current with industry trends and emerging technologies.
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